a study of the safety and pharmacokinetics of brcx014 in patients with glioblastoma

Conditions: Glioblastoma

Summary: an open-label, multi-center study to assess the safety and pharmacokinetics of brcx014 combined with standard-of-care treatment in subjects with glioblastoma

several studies have shown a possible anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, and overcoming chemotherapy resistance. the investigators seek to demonstrate the safety profile of brcx014, a cannabinoid formulation, when given to glioblastoma patients in conjunction with standard-of-care therapy.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed glioblastoma (astrocytoma who grade iv) * mgmt promoter methylation status is negative * brain mri confirmation of disease according to rano (response assessment in neuro-oncology) criteria * completion of standard-of-care temozolomide-based chemoradiation for post-operative treatment of glioblastoma plus two-to-six week "washout" period and stable-to-improved baseline brain mri. * male and female subjects between the ages of 18 and 85 years * karnofsky performance score ≥ 60% * expected survival of at least six months from the day of enrollment * no severe dysfunction of major organs (e.g., bone marrow, liver, kidneys, heart, lungs, etc.) and laboratory results from up to 14 days prior to enrollment fall within criteria: * hemoglobin \> 10 g/dl * leukocytes ≥ 3,000 per μl * absolute neutrophil count ≥ 1,500 per μl * platelet count \> 100,000 per μl * bun \< 25 mg * serum creatinine within normal institutional limits or creatinine clearance ≥ 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal * total serum bilirubin within normal institutional limits * alt (sgpt) ≤ 2.5× the institutional upper limit of normal or ast (sgot) ≤ 2.5× the institutional upper limit of normal * ability to take medication sublingually * willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures * accessible for treatment and follow-up * female subjects: use of two approved forms of contraceptives * male subjects: use of two approved forms of contraceptives and willing to instruct their partners to use one form of contraceptive as well * ability to understand and willingness to sign a written informed consent document exclusion criteria: * mgmt promoter methylation status is positive (i.e., promoter is methylated) * prior radiotherapy for gbm within two (2) weeks of entering the study or has not recovered from adverse events due to agents administered more than four (4) weeks earlier * prior chemotherapy, immunotherapy, or radiation therapy for other cancers (except for treatment of limited curable skin cancers) * currently or recently (in the previous six months) part of a clinical trial involving any other investigational agents * hypersensitivity or allergy to any ingredient in the study drug * receiving any medications or substances that are known substantial inhibitors or inducers of cyp3a4 * consumption of grapefruit or grapefruit juice three (3) days prior to screening or unwillingness to abstain from consuming grapefruit in any form during the study * uncontrolled intercurrent illness that would limit compliance with study requirements * pregnancy, possible pregnancy, plans for pregnancy, or active lactation or nursing * positive hiv or hepatitis status * unwillingness or inability to take medication sublingually * diagnosis of cancer more than 120 days prior to initial visit * history of prior malignancy except curatively treated skin cancers * history of prior chemotherapy or radiation for other cancers (except for treatment of limited curable skin cancers) before initial visit * clinically significant unstable medical conditions other than gbm * clinically relevant symptoms or clinically significant illness in the four (4) weeks prior to screening or registration, other than gbm * clinically significant unstable medical conditions, other than gbm, deemed by the investigator to pose an unacceptable risk to the patient * history of substance abuse within the last two years * current use of recreational or medicinal cannabis, synthetic cannabinoid-based medications, or alcohol, or planned use while in the study * evidence of any diseases or conditions that may interfere with the study or interpretation of study results * inability or unwillingness to cooperate with the study procedures * known history of severe depression or psychiatric disorders, or active suicidal ideation * subjects with close affiliation with an investigational site * absence of or unwillingness to sign and date the informed consent document